Program Quality Manager (PQM)

Full-time

FUJIFILM Biotechnologies

Position Overview
The Program Quality Manager (PQM) serves as the primary liaison between customers and the FUJIFILM Biotechnologies, Holly Springs project team from the point of contract signature through program closure. This role works with customers and FUJIFILM Biotechnologies, Holly Springs project teams to align QC objectives and initiatives in contracted commitments with FUJIFILM Biotechnologies, Holly Springs Analytical Method Capabilities and the FUJIFILM Biotechnologies, Holly Springs company vision/mission (strategy and compliance). The Program Quality Manager ensures the timely completion of QC deliverables for customer programs. The Program Quality Manager handles an average load of 2-4 customer programs.
Company Overview
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.
We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!
Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit:
Job Description
What You'll Do
Acts as primary QC contact for external customers and partners for all FUJIFILM Biotechnologies QC teams involved in the customer collaboration.
Understands and communicates customer quality needs and requirements to internal teams, including QC teams.
Supports the Sales Team in the initial draft Scope of Work (SOW) related to QC analytical methods and testing and engages impacted QC functional areas for inputs to ensure the analytical method transfer and validation expectations are complete and realistic.
Supports the generation of contracts and amendments to Quality Agreements, Statements of Work, and Master Service Agreements together with the global Commercial Development team and Quality Assurance.
Leads, coordinates, and facilitates meetings between clients and QC tech transfer leads to ensure high performance of QC activities.
Represents QC in cross-functional meetings including but not limited to: Program Kickoffs (Internal & Client), Program Status (Internal and Client), Project Teams, and steering committee membership (as needed).
Drives/participates in Quality management meetings where relevant Key Performance Indicators are shared.
Drives QC project management initiatives related to tech transfer of analytical methods, external testing with CLOs, and timely delivery of client commitments.
Organizes, leads, and facilitates QC project teams for client programs. Provides a standard agenda and meeting summaries (discussion points, decisions, action-risk log). Implements a project team meeting cadence which enables appropriate internal discussions and client engagement/communication. Assigns and tracks specific functional accountabilities.
Creates, organizes, and communicates status of QC projects to clients, QC teams, and leadership using project management tools.
Provides timely responses to clients including but not limited to communications involving operational readiness for analytical capabilities, requests for information, deviations, change management, product disposition, and other QC deliverables.
Attends and participates in appropriate internal meetings to provide QC-related program updates. Ensures all QC-related action items are completed per the committed timing. Ensures that appropriate escalation occurs for unresolved QC-related issues & risks.
Collaborates cross-functionally with other FUJIFILM Biotechnologies, Holly Springs teams and across FUJIFILM Biotechnologies sites and prioritize deliverables.
Adheres to the global quality system and supports handling of tasks in accordance with Statement of Works and Quality Agreement.
Performs other duties, as assigned.
Knowledge, Skills, and Abilities
Knowledge of GMP and quality systems.
Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals.
Excellent oral and written communications skills and fluency in English.
Excellent organizational and critical thinking skills.
Attention to detail and commitment to maintaining the quality standard.
Ability to navigate complex stakeholder interactions.
Commitment to sustainability and innovative solutions.
Problem solving & conflict resolution.
Ability to manage multiple assignments while meeting timelines in a GMP environment.
Understanding of analytical methods and working in a GLP or GMP laboratory.
Minimum Qualifications
Bachelor's in Life Sciences, Chemistry or Engineering or equivalent with 5+ years of applicable industry experience, OR;
Masters in Life Sciences, Chemistry or Engineering and 3+ years of applicable experience, OR;
PhD in Life Sciences, Chemistry or Engineering and 0+ years of applicable experience.
5+ years of project management experience preferably in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO).
1-3 years' experience in customer relationship management.
1-3 years experience in a GMP environment.
Preferred Qualifications
Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting.
Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to:
Ability to discern audible cues.
Ability to stand for prolonged periods of time for up to 30 minutes.
Ability to sit for prolonged periods of time for up to 120 minutes.
Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
Ability to conduct work that includes moving objects up to 10 pounds.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
*LI-Onsite
EEO Information
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
ADA Information
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (View email address on us.fitly.work).

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Vacancy posted 3 days ago

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